Thursday, November 4, 2010

Is Your Doctor a "Return on Investment"?

Ever since ProPublica published its disturbing database called Dollars for Docs, there have been many local news stories written about hired gun physicians who take money from drug companies to promote drugs to other doctors. A particularly good one was published yesterday in the SentinelSource by the Chicago Tribune's Judith Graham.

The Tribune interviewed about a dozen physicians who make thousands per year from drug company talks, and, according to Graham, "all said they believe such ties have no effect on their medical practices."

But Graham also interviewed a former drug rep, who provided the unvarnished and rather ugly truth about how these apparently well-meaning doctors are actually being manipulated by their handlers:

"Angie Maher, a former Michigan drug sales representative turned whistle-blower, described training sessions where psychologists and coaches would brief her on how to play on doctors’ vulnerabilities — their desire to feel important, their eagerness to be on the cutting edge — while working to boost sales. Each time a physician would give a talk, Maher would fill out a “return on investment” spreadsheet tracking prescription trends for all the doctors who attended the event. If sales went up, the speaker was asked to give another presentation, she said. If not, further invitations to speak would not be extended."

That says it all. Time for these doctors to wake up and realize that have transformed themselves into ROIs for their sponsoring companies.

"Fair reporting should include quotes from uninterested and unbiased parties such as whistle blowers who stand to make millions if they win."

I read the article and I didn't see any mention of the whistle-blower pharma rep having filed any lawsuit, let alone a lawsuit with a potential payoff of millions. Some whistleblowers come clean without a financial incentive. You're right...no conflicts here.

Nor was there mention of ROI from the use of an advanced medication with fewer side effects, on health care costs, on economic savings to the patient, and on the value of less suffering with the use of a new product.

These ideologues would have us still doing vagotomy, pyloroplasty, and antrectomy, rather than promoting a new H2 blocker.

The alternative to these pharmaceutical advances are massive, costly, government financed services. That is what the left is promoting, and that is their return on investment from these unwarranted witch hunts.

David, It appears that your core argument is that in matters of bribery, the ends justify the means. Boston has been racked by political bribery for decades--recently there have been several cases of city council members taking cash payments in order to exert their influence over colleagues to obtain permits for restaurants or other businesses. We define this type of influence as illegal, because it is essentially undemocratic--it bypasses the system of representational democracy that we value. It seems that the logical extension of your "show me the harm" argument is that you would condone such bribery as long as the resulting building permits led to a nice restaurant or a beautiful skyscraper. The end result may at times be beneficial, but the process is unethical.

Is commissioned work by public employees deleterious? Give public workers a low salary, then those using them pay for successful completion of an assignment. If people are telling the truth, this is a great system that would speed up government reviews and licensing by a factor of 10. The reason we do not allow it is that people will lie. They take money and will give a certificate of health to a dirty restaurant. People will eat there, and get sick. That is a harm.

In the case of pharmaceuticals, there has never been a proven harm from off label promotion, or sponsored activity. Indeed, there has been a tremendous benefit. Off label use is the single biggest source of clinical innovation at no additional expense.

You felt unduly influenced by the pay you received. However, I felt a sense of sacrifice, since that pay was half my usual hourly rate after counting preparing (by studying), travel, waiting, talking to a doctor, and travel back. I had to limit these, not for any moral qualm, but because the pay was too little.

It is common ground between us, that candor about a treatment is mandatory. What should reassure patients is that any false claims or exaggerated claims will be rebutted by the experiences of any doctor the company tried to fool, and then the product is sunk. This principle does not apply to newly reported side effects emerging from use in large, non-testing, non-selected populations.

There are gigantic, nearly irremediable problems with the entire medical research enterprise. All of its results may be fictional, for example, even if candidly reported. Paid advertising and promotion effects are trivial, marginal, and for the most part beneficial for patients.

I would be willing to put government officials on a small salary, and give them large commissions for getting things done. What do you think would happen to their speed, their competence, and their scope of service (as in, "It's not my job," or, "Sorry, the post office closes at 5 PM, and it is now 5:01 PM. Bring your package back tomorrow.")?

If the ends justify the means, the regulations prohibiting the means are wrongheaded.

Is commissioned work by public employees deleterious? Give public workers a low salary, then those using them pay for successful completion of an assignment. If people are telling the truth, this is a great system that would speed up government reviews and licensing by a factor of 10. The reason we do not allow it is that people will lie. They take money and will give a certificate of health to a dirty restaurant. People will eat there, and get sick. That is a harm.

In the case of pharmaceuticals, there has never been a proven harm from off label promotion, or sponsored activity. Indeed, there has been a tremendous benefit. Off label use is the single biggest source of clinical innovation at no additional expense.

You felt unduly influenced by the pay you received. However, I felt a sense of sacrifice, since that pay was half my usual hourly rate after counting preparing (by studying), travel, waiting, talking to a doctor, and travel back. I had to limit these, not for any moral qualm, but because the pay was too little.

It is common ground between us, that candor about a treatment is mandatory. What should reassure patients is that any false claims or exaggerated claims will be rebutted by the experiences of any doctor the company tried to fool, and then the product is sunk. This principle does not apply to newly reported side effects emerging from use in large, non-testing, non-selected populations.

There are gigantic, nearly irremediable problems with the entire medical research enterprise. All of its results may be fictional, for example, even if candidly reported. Paid advertising and promotion effects are trivial, marginal, and for the most part beneficial for patients.

If the ends justify the means, the regulations prohibiting the means are wrongheaded.

You state "Nor was there mention of ROI from the use of an advanced medication with fewer side effects, on health care costs, on economic savings to the patient, and on the value of less suffering with the use of a new product. "

I take this to mean that you consider the new products to be better for patients than the older ones. The literature I am aware of disproves this hypothesis for many new products and procedures.

Your statement seems central to your argument so please let me know what evidence you have to support it.

Joe: I would like to come over and to give your dog Haldol 2 mg. Would you let me? Your dog probably already drools, so there will be little difference in his appearance. That is the aim behind the current campaign. The hierarchy does not want dark skinned people on Medicaid to receive expensive brand medication. If not acceptable in a dog, why acceptable in our patients? [I am not suggesting use of first generation medication is beyond the standard of care, and could defend a doctor who used them first with the data to which you are referring.]

In a survey of various mental health workers, most not eligible to be drug company speakers, only 3% said that first generation tranquilizers would be acceptable for themselves. Beyond the data, which is problematic, that is a gut level, bottom line, take home message. Very sick patients who do not wish to learn a medical sub-specialty, when faced with a difficult decision, will ask the same question, "Doctor, in my place, what would you do personally?"

I do not see how your reply is evidence for your statement that advanced medications have fewer side effects or less mordibity.

I am assuming your comments on Haldol are referring to a study that suggested that second generation antipsychotics were essentially no different from first generation antipsychotics. Since I don't work with many psychotic patients, it would have helped me if you had provided evidence that the study was flawed in some manner, or cited an existing critique of that study.

However, I was not referring to that study in my request for evidence supporting your statement that "advanced" medications were better. I have seen numerous articles that appear to demonstrate that newer medications which are heavily marketed are not better than older medications. For example, Vioxx vs Ibuprofen. SNRI's vs SSRI's.

Some new medications do seem to be definite improvements. I find SSRI's to be far safer than TCAs and MAOIs for treating depression. But the marketing seems to be unrelated to the benefit of the medication.

I think that Danny's point is that the speaker is chosen as a speaker because the pharmaceutical company observes an increase in sales that is significantly greater than the cost of the speaker. If a speaker does not charge much, then the ROI for the pharmaceutical company is that much higher. The speaker may feel better ethically, but that does not mean that their talk is more scientific because, from the evidence Danny provides, the company is not interested in science.

Evidence based medicine is itself mostly garbage. Most studies use statistics based on the bell curve. The studies violate the central assumption of that statistic, random selection, by having exclusion criteria, e.g. suicidal patients. This statistic will accurately predict the rates of response of a larger population. They cannot be applied to individual clinical decisions. These are better described by the binomial distribution. That subject is covered Day 1 of 11th grade Statistics, when discussing coin tosses. Response or non-response, and move on to another drug trial. It seems no one in the medical hierarchy took 11th grade Statistics, or else they cut class the first day. Maddening. They are all applying parametric statistics (bell curve) to binomial situations.

It is also impossible to know whether any subject ever swallowed either medication or placebo. Studies never provide blood levels.

Because the studies are done in academia, they are delayed and confirmatory. Grant review committees want only positive findings, and will fund only "sure things." The only way to get that is to fund a study of the medicine of 5 years ago.

So evidence based medicine is garbage, obsolete, irrelevant science.

I suppose the drug companies are doing the same thing as clinical care, response or non-response, move on to another trial of speakers. That is their duty to the shareholders.

The duty of the doctor is to tell the truth of his clinical experience. At the group level, Vioxx may equal ibuprofen. At the level of the 5 million patients on Vioxx, taking it off the market was very disruptive. That decision should have been left to the patients and their doctors. Many had failed to respond to anything else.

It is nothing less than pathetic how people rationalize and/or minimize the concept of reciprocity as either means to an end or just "that's just the way it is", and then move on like their perspective is the only one.

And these are more often people who have higher degrees, or at least give the impression they are somewhat well educated. Well, until we get to the point that the meek may inherit the earth, I guess we'll have to deal with the weak will continue to disrupt the earth.

This is not rocket science, folks. You take money from people who have expectations, you are either inconsiderate, clueless, or a thief to not think of the source when they call on you for your acceptance of their offerings.

Joel: Personal remarks show frustration in the debate, including the implication a crime has been committed ("thief").

You left out one possibility, perhaps out of personal bias.

The pay is too low, and represents an economic sacrifice for the sake of teaching, and more often, learning from clever, experienced colleagues. I lost thousands of dollars on these underpaid activities, and have ended them for that economic reason. The pay is nearly insulting, in its devaluation of the clinician's time and effort.

Also, to avoid the accusation of hypocrisy, you have to report not watching the Superbowl for free, so as to not "steal" a very expensive show, in exchange for watching commercials. Those are the best commercials on earth. Did they induce you to use a product that you did not need or that harmed you once?

I believe in criminalizing conduct that harms people. The opposite is true, a benefit to patients has been committed. Sponsored activity should be encouraged by the government. The benefit comes from the sharing of information about how to use new medications, and the reporting by experienced clinicians of adverse events not yet published. No harm can be shown from sponsored activity, because there is none.

The government is on this witch hunt to prevent dark skinned people on Medicaid from receiving brand name medications, instead of generics you would not allow in your dog. There would be no discussion if all our patients were white.

Dr Behar states "there has never been a proven harm from off label promotion, or sponsored activity." Exactly what kind of harm are you looking for? Is it not harmful to promote the use of a drug that has limited clinical support for an approved use knowing full well that it is likely to be used on pts who have not been told of the potential risks and lack of science to support its use? I see this over and over and over every day. When I inform them of such they do not seem too happy.

"What should reassure patients is that any false claims or exaggerated claims will be rebutted by the experiences of any doctor the company tried to fool, and then the product is sunk."

ahh...You have to be kidding me. Drs are some of the easiest people in the world to fool. Anybody with even a terse understanding of the h/o medicine should understand this.If you draw up a list of effective medical technologies that actually serve to extend life or reduce pain before the middle of the 19th century, that list is very short and there is a very long list of foolish Drs.

Despite a mountain of evidence that my psychotic dog would do just as well on his Haldol as your new Abilify(not very well) you think the only reason it is being denied is "The hierarchy does not want dark skinned people on Medicaid to receive expensive brand medication." What evidence do you have to support this mass conspiracy against those with dark skin? Please name some names.

Have you ever asked yourself why so many dark skinned people on medicaid are even being given antipsychotics to begin with?

Just because you poll a bunch of misinformed non-pharma sponsored mental health workers about what flavor anti-psychotic they want and they respond in lock step just like their pharma sponsored doctors taught them to does not support the contention that new drugs are any better than old ones. I am sure if you had asked a bunch of non- bloodletting healthcare workers in the 1700's if they would want only the latest approaches to bloodletting for themselves, family or their dogs they would have responded with a hearty yes despite not being eligible to do pharma funded promotional talks on bloodletting ! You ever hear of the "herd mentality"?

Hope this link below shows readers the blurred boundaries between drug reps and healthcare professionals. A two part story in the Baltimore Sun, part 2 this morning talks of how this addiction program called Baltimore Behavioral Health questionably handled using patients and accessing housing for patients/clients care. In this link, and I strongly advise anyone who liked this part to go and read part 1 run on Sunday, you'll read in the end how J&J reps bought houses and then rented them to BBH, while calling on their docs as well.

I wish I could provide my comments about what I have observed, peripherally I will state up front, but I think the article says it well for me! Another black eye for psychiatry, which is more apparent in part 1.

Oh well, it just reinforces to me you better beware when you turn to addicts to treat addicts. And I am not talking solely about chemical addiction here. You, the readers, learn for yourselves.

And, I agree with the above commenter who notes "herd mentality", although in this case I would deem it "heard mentality".

"In the case of pharmaceuticals, there has never been a proven harm from off label promotion, or sponsored activity."

I beg to differ. How about Eli Lilly's "5 at 5" promotion for use of Zyprexia in nursing homes to quiet those pesky patients down in the evening so the staff could watch sitcoms on television? Only, the Zyprexa increased the patients' risk of dying. Ooops. I believe Eli Lilly paid about $615million at least in part for that little faux pas.

Then there are the thousands kids in the juvenile (justice system receiving atypical antipsychotics off label as a means of chemical restraint, just to keep them pacified. Of course the massive weight gain, risk of diabetes and possibly irreversible damage to their neurochemical systems aren't harmful, right?

And I won't even get started on the use of atypical antipsychotics on "bipolar" two year olds.

Really, you look very far or think very hard to see the damage from off-label promotion of drugs.

I can't reply to personal remarks because they come from the frustration of the utterer with the facts.

As to the list of harms from Anonymous.

There is an established doctrine called the learned intermediary doctrine. It basically states that once the drug company has informed doctors about a new side effect they are not responsible for the resulting damages.

The learned intermediary who is the doctor has a duty to the patient to provide care within professional standards. The best description of the standard of care is what the mainstream is doing. You are describing side effects well known to anyone using the medications from year 1. The fact that 100's of 1000's of people were placed on these medications shows, 1) they worked; 2) they were the best available remedy available, and those not using them were performing substandard care; 3) the benefits outweighed the risks in the joint decision of the doctor and responsible decision maker.

If I tell you that 500,000 kids are on Abilify, that fact alone is the best indicator of efficacy off label, and far more compelling to use the medication than any study you might design, even one that included 10,000 patients and turned out to be inferior to placebo. There would be something wrong with the study before the treatment would be stopped. It is impossible to have a treatment be so widespread that is not effective, nor the best available at the time.

We now know that probing a bullet wound with filthy fingers is outrageously harmful to the patient. We know that everything we are doing today will be even more outrageous to doctors 100 years from now. But, that is the best available at this time.

Off label uses are the single biggest source of clinical advances at no additional cost. Not only should the witch hunt stop, but systemic research should be initiated to find many more off label uses.

Dr Behar says,"The fact that 100's of 1000's of people were placed on these medications shows, 1) they worked." By this same logic all of these things work:1)Lobotomy2)Compulsory AA3)Faith Healing4)Blood letting5)Cold water immersion6)HomeopathyThe list is endless.

I am sure Dr B believes each and every antibiotic prescription handed out for cold symptoms currently "works".I mean Drs would never prescribe them otherwise right?

I could go on forever. Just listing lots of useless TX that is widespread will be interpreted by Dr B as a personal attack by the frustrated. In his world ""It is impossible to have a treatment be so widespread that is not effective"

How do you argue with that kind of wisdom?

Drs are woefully ignorant on the concept of Iatrogenisis and this debate is evidence of that. I am afraid I'm late for my daily high colonic.

“The whole problem with the world is that fools and fanatics are always so certain of themselves, and wiser people so full of doubts.”Bertrand Russel

Dr. John cites treatments not used for decades. They were replaced by modern psychopharmacology. He is making my point, that the alternatives are unacceptable.

One notes his failure to list psychoanalysis, a cult procedure, invented by a real wack job, flying high on cocaine all day. It is the biggest loser from modern psychopharmacology, especially off label use in the "neuroses."

Dr. Dan would like to see more of it come back, and perhaps Dr. John is also an adherent of this wacky delusional method of treatment.

"There is an established doctrine called the learned intermediary doctrine. It basically states that once the drug company has informed doctors about a new side effect they are not responsible for the resulting damages." Ummm....no, that's not what the learned intermediary doctrine means.

I'm not sure how you go from the learned intermediary doctrine--which is a legal doctrine concerning the element of causation--to the conclusion that if 1000's of doctors are prescribing a drug to 1000's of patients, that is proof that the drug is safe and effective. One just does not follow from the other.

One of the problems with pharma-sponsored indoctrination, um, I mean education, for doctors is that it does not help them become learned intermediaries. In fact, it has the opposite effect--they only hear what the pharma companies want them to hear. Doctors don't have time to carefully read and understand the underlying drug studies. They rely on their CME to boil it down for them. Unfortunately, when pharma funds the CLE, the doctors just become tools of the industry. Intermediaries, yes, but not learned in any real sense.

A doctor prescribes, but a patient swallows the treatment day after day because it serves his interest. The biggest obstacle to successful clinical care is non-adherence, including the 40% of organ transplant rejections caused by it. These pompous, fact free, officious intermeddlers know far more about what is good for patients than patients themselves. Their irresponsible claims encourage non-adherence, and so we have 30,000 suicides and 3000 murders by untreated paranoid schizophrenics, thanks to the lawyer and to the irresponsible left.

Anon, JD, is a bit misleading in a self serving way. The FDA wants to channel drug company warning through doctors. Anon JD would like to go around this federal pre-emption to sue drug makers in state court. This will drive out all vaccines, all drug innovations, and the superiority of American drug inventions, as lawyer bought off judges and juries plunder this small island of remaining US success. Thank the lawyer when there are no vaccines, no new medications, and all that remains in psychiatry is talk therapy.

Tha Atlantic Monthly had a great article on this topic in 2006. One point they made was that the primary target of their co-opting docs to give propaganda talks for other sheep, er, docs was not the audience but rather the speaker her/himself. Their aim was to find the "high prescribers. (we all know those kind in our communities) and reinforce their behavior with $$ and the ego stroke of being a "thought leader"- even as the "mark" was simply reading slides from the pharma's marketing dept, like selling a sham-wow. Here's the link: http://www.theatlantic.com/magazine/archive/2006/04/the-drug-pushers/4714/

"The list" was front page news on the Des Moines Register Sunday. I would like to see this type of disclosure continue. If this activity is completely ethical, then why would any drug company or doctor object?

It is new for me that physicians who take money from drug companies to promote drugs to other doctors. They take money and will give a certificate of health to a dirty restaurant. We define this type of influence as illegal, because it is essentially undemocratic.